Last updated: 11/03/2018 22:14:22
Efficacy of Topical Indomethacin Patch over Placebo in Ankle Sprain Pain relief
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study to Assess the Efficacy of Pain Relief of Topical Indomethacin Patch over Placebo in Ankle Sprain Patients
Trial description: This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Sum of Pain Intensity Difference (SPID)1-3 days
Timeframe: Baseline (Day 1) to Day 3
Secondary outcomes:
Pain Relief Score (PRS) on movement over time
Timeframe: 30 minutes (mins) to 144 hours (hrs) post treatment
NRS for pain on movement over time
Timeframe: 30 mins to 144 hr post treatment
Change from baseline in NRS at rest
Timeframe: Baseline (Day 1) to Day 7
Time to onset of pain relief
Timeframe: Baseline (Day 1) to Day 3
Assessment of Sum of Pain Intensity Difference (SPID) on movement
Timeframe: Baseline (Day 1) to Day 7
Sum of Pain Intensity Difference and Pain Relief (SPRID) on movement
Timeframe: Baseline (Day 1) to Day 7
Total Pain Relief (TOTPAR) on movement
Timeframe: Baseline (Day 1) to Day 7
Patients' global assessment to treatment
Timeframe: Baseline (Day 1) to Day 14
Rate of rescue medication use
Timeframe: Baseline (Day 1) to Day 14
Time to first dose of rescue medication use
Timeframe: Baseline (Day 1) to Day 14
Total dose of rescue medication use
Timeframe: Baseline (Day 1) to Day 14
Interventions:
Drug: Indomethacin
Drug: Placebo
Enrollment:
270
Observational study model:
Not applicable
Primary completion date:
2014-14-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Ankle Sprain
Product
indometacin
Collaborators
Rundo International Pharmaceutical Research & Development Co., Ltd
Study date(s)
October 2013 to September 2014
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit
- Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participant who had medication that could interfere with the subject’s perception of pain since experiencing ankle sprain.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit
- Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating.
- Participant with a peri-malleolar edema (sub-malleolar perimeter difference of >=20mm between injured and uninjured ankle)
Exclusion criteria:
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participant who had medication that could interfere with the subject’s perception of pain since experiencing ankle sprain.
- Pregnancy , Breast Feeding and Substance Abuse
Trial location(s)
Location
Shanghai First People's Hospital
Shanghai, Shanghai, China, 201620
Status
Study Complete
Location
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Status
Study Complete
Location
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Status
Study Complete
Location
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China, 213003
Status
Study Complete
Location
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200092
Status
Study Complete
Location
Shanghai Tenth People's Hospital
Shanghai, Shanghai, China, 200072
Status
Study Complete
Location
Shanghai Xuhui Centre Hospital
Shanghai, Shanghai, China, 200031
Status
Terminated/Withdrawn
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2014-14-09
Actual study completion date
2014-14-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website